Sr. AD, QC ASAT, Fremont CA

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Sr. AD, QC ASAT and leads the analytical science and technology function that enables rapid, compliant onboarding of new client products and robust lifecycle management of methods for commercial GMP manufacturing. This role oversees method validation/transfer (per ICH Q2(R2)/Q14), specification setting and maintenance, reference standard and critical reagent programs, stability program ownership, analytical trending & control charts, and technical consulting for investigations, OOS/OOT, and compliance.

The leader will also own or oversee local Management System Owners (MSOs) for Stability, OOS, Testing Specifications, and Reference Standards to ensure strong governance, inspection readiness, and continuous improvement.

This position offers a base salary typically between (170,000) and (269,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information.

Strategic Leadership & Vision

• Ensure that Quality Culture principles and company goals are clearly understood and embraced by all team members. Role model Our Behaviors and actively foster a culture of integrity, collaboration, and accountability, encouraging adherence and engagement across the team.
• Define and implement the strategic direction for QC department in alignment with site and global objectives with focus on compliance.
• Drive and lead standardization and harmonization of QC practices and across the global network.
• Sponsor and lead initiatives that enhance lab excellence, modernization, digital transformation.
• Shape and contribute to global QC standards, policies, and processes.

New Product or Method introduction

• New Product Introduction (NPI) & Tech Transfer:
  Plan and execute analytical strategy for incoming products—gap assessments, risk assessments, method readiness plans, validation/transfer protocols, execution, and reports, stability program, reference standard qualification.
• Method Validation/
  
  Qualification:
  
  Ensure phase-appropriate design and execution (ICH Q2(R2)), robustness/risk assessments, and data packages suitable for PPQ and commercial control.
• Apply risk-based decision-making to balance compliance and operational efficiency for complex and high-impact situations.
• Regulatory & Audit Readiness:
  Support client/regulatory inspections, author/review source documents, and ensure alignment with filings and global guidelines.

Project Team & Client interface

• Act as QC representative in internal and external client project teams.
• Ensure QC deliverables meet global and local regulatory expectations.
• Ensure newly implemented products and methods adhere to timeline and budget within QC.
• Initiates generation of change orders in case of scope change

Analytical Lifecycle Management and Support

• Method Lifecycle Management:
  Establish control strategy and performance monitoring aligned to ICH Q14, including ongoing trending, control charts, periodic reviews, and continuous improvement.
• Designs programs for qualification and requalification of critical reagents and reference standards.
• Responsible for setting up and monitoring the ongoing stability program in accordance with regulatory requirements, client requirements and internal procedure

Team Leadership & Development

• Lead, coach, and mentor…